Pharma Production Brochure - EMD Chemicals

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EMPROVE® A strong brand Is the safety of your products your top priority? Do your formulations require excipients and agents that are always in line with the latest regulatory requirements? EMD is the right supplier and partner to help you fulfill these and many other requirements. 18 EMD for Pharmaceutical Production · www .emdchemicals .com Regulatory measures are causing developments on an international level in the pharmaceutical industry. While these measures aim to increase safety and reliability, they also have long-term consequences. The further development of GMP requirements in causing the market for pharmaceutical raw materials to change on an ongoing basis. It is also likely that the excipients group will face regulation in the foreseeable future. With its EMPROVE® brand, EMD is already setting the standard in excipients. Closely based on the Common Technical Document (CTD) standard, it identifies and documents information and data. The documents are then compiled and completed in the EMPROVE® dossier. Partial dossiers are also available. Updates are provided either when major changes are made, or after 12 months at the latest. For detailed information, see www.emprove.merck.de. How does EMD prepare for the future? The issue of drug safety is constantly gaining importance in the public arena and in the statutory context. We see this trend from the patient's viewpoint and fully support it. As one of the leading producers of excipients for the pharmaceutical industry, we embrace our responsibilities. EMPROVE® is a step in the right direction, but is by no means the final step. That is why EMD is actively involved in introducing appropriate regulations for excipients.
There are also different requirements for different uses of agents and basic materials in the pharmaceutical process. For this reason, in order to be able to support our customers even more effectively, we have oriented our products in EMPROVE® more strongly around their areas of use. EMPROVE® specialties: · EMPROVE® exp for use as an excipient* · EMPROVE® api for use as an active pharmaceutical ingredient* · EMPROVE® bio for use in biopharmaceutical production * incl. stability data From the middle of 2008, we will offer our registered customers a special service: the Basic Dossier both in online form and as a download. To ensure that our customers always have the very latest information, the online data will be updated frequently. The EMPROVE® dossiers “Test Specification” and “Stability” are available on request, after completion of a non-disclosure agreement. With EMPROVE®, EMD provides its customers with a high level of production safety. The quality of our raw materials and our extensive documentation enable you to do your work quickly and cost-effectively. Make sure that you get the full benefit of everything EMPROVE® has to offer. EMD for Pharmaceutical Production · www .emdchemicals .com 19
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Pharma Production Brochure - EMD Chemicals

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